Additional 12-week outcome data from the multinational, double-blind, phase 2bof bimekizumab in patients with active AS were presented by Désirée van der Heijde, MD, PhD, of Leiden (the Netherlands) University Medical Center.
Unlike secukinumab and most of the other anti–IL-17 receptor monoclonal antibodies in development, bimekizumab inhibits IL-17F in addition to IL-17A, according to Dr. van der Heijde. She cited experimental evidence suggesting that inhibition of both forms of IL-17 results in greater anti-inflammatory response.
In the initial and previously reported data from this dose-ranging study of 303 AS patients, all four doses of bimekizumab (16 mg, 64 mg, 160 mg, or 320 mg) were superior to placebo for the primary endpoint of ASAS40. However, greater relative benefit was observed for the three highest doses.
In the new analysis, symptoms were evaluated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). At 12 weeks, 47.5% of patients on the highest dose of bimekizumab versus only 11.9% of patients randomized to placebo achieved a 50% or greater level of improvement on the BASDAI, called BASDAI 50 (P less than .001).
The greater clinical activity of bimekizumab relative to placebo translated into improvement from baseline in Ankylosing Spondylitis Quality of Life scores. Greater reductions in Ankylosing Spondylitis Quality of Life scores relative to placebo, signaling an improved quality of life, were achieved with all doses, but they reached 4.6 points for the highest dose versus only 1.3 for placebo.
When evaluated with Patient Global Assessment of Disease Activity, another tool that reflects perception of disease burden, the score reduction was 3.3 points for the highest dose versus 1.0 points for placebo. Dr. van der Heijde characterized the reductions at the highest doses versus placebo as “significant” although she did not provide P values.
Like the data presented on the other newer anti–IL-17 therapies, bimekizumab was well tolerated with relatively low rates of adverse events, most of which were mild to moderate in severity, according to Dr. van der Heijde.
“The data from the BE AGILE trial supports phase 3 development in AS,” Dr. van der Heijde said. She noted that trials are also being planned in axSpA.
All three presenting authors reported multiple financial relationships with pharmaceutical companies, including, in each case, the pharmaceutical company that sponsored the trial they presented.
SOURCES: Gaydukova I et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193-4, ; Wei JC et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):195, ; van der Heijde D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):193, .